Cleared Traditional

K254026 - 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U)

Also marketed or referenced as:
5.0mm Regular ProVu Video Bronchoscope (090-02-0050U) 6.0mm Large ProVu Video Bronchoscope (090-02-0060U) ProVu Video Bronchoscope 8 display (040-07-0082U)

K254026 is an FDA 510(k) clearance for 3.8mm Slim ProVu Video Bronchoscope (09..., manufactured by Flexicare Medical Limited.. The device is a Class 2 Ear, Nose, Throat device with product code EOQ cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K254026 · Flexicare Medical Limited. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
260d
Days
Class 2
Risk

K254026 is an FDA 510(k) clearance for the 3.8mm Slim ProVu Video Bronchoscope (090-02-0038U). Classified as Bronchoscope (flexible Or Rigid) (product code EOQ), Class II - Special Controls.

Submitted by Flexicare Medical Limited. (Rhondda Cynon Taf, GB). The FDA issued a Cleared decision on September 2, 2026 after a review of 260 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4680 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Flexicare Medical Limited. devices

FDA 510(k) Submission Details - K254026

510(k) Number K254026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2025
Decision Date September 02, 2026
Days to Decision 260 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 90d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EOQ Device Classification - Class 2, Special Controls

Product Code EOQ Bronchoscope (flexible Or Rigid)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.4680
Definition A Bronchoscope (flexible Or Rigid) And Accessories Is A Tubular Endoscopic Device With Any Of A Group Of Accessory Devices Which Attach To The Bronchoscope And Is Intended To Examine Or Treat The Larynx And Tracheobronchial Tree. If The Device Is Reprocessed, Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - EOQ Bronchoscope (flexible Or Rigid)

All 221
Devices cleared under the same product code (EOQ) and FDA review panel - the closest regulatory comparables to K254026.
Single-use Flexible Bronchoscope
K261637 · Hunan Vathin Medical Instrument Co., Ltd. · Sep 2026
Ambu® aScope™ 5 Broncho 2.7/1.2
K260309 · Ambu A/S · Sep 2026
MONARCH™ Platform (MON-000008)
K260382 · Auris Health, Inc. · Jul 2026
LungFlow Airway Catheter
K254037 · Free Flow Medical, Inc. · Jul 2026
FUJIFILM Endoscope Model EB-840S
K253137 · Fujifilm Corporation · Jun 2026
SmartClip Delivery Catheter (ADR-1715)
K260565 · Elucent Medical · May 2026